510(k) K210143
K210143 is an FDA 510(k) premarket notification submitted by Foshan Nanhai Plus Medical Co, Ltd. for the device "Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)". The FDA issued a decision of Substantially Equivalent on July 22, 2021. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Foshan Nanhai Plus Medical Co, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2021
- Date Received
- January 19, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type